Clinical trial
A Two-part Phase I Study Composed of a Randomized, Double-blind, 4-parallel Group Study to Evaluate the Effect of Multiple Oral Doses of GFT505 on the QT/QTc Interval Compared to Placebo With Moxifloxacin (400 mg in Single Oral Dose) as a Positive Control, in Healthy Male and Female Volunteers, Preceded by a Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define the Supra-therapeutic GFT505 Dose in a Multiple Dosing Regimen.
NCT02091310 is registered in ClinicalTrials.gov with Genfit as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Two-part Phase I Study Composed of a Randomized, Double-blind, 4-parallel Group Study to Evaluate the Effect of Multiple Oral Doses of GFT505 on the QT/QTc Interval Compared to Placebo With Moxifloxacin (400 mg in Single Oral Dose) as a Positive Control, in Healthy Male and Female Volunteers, Preceded by a Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define the Supra-therapeutic GFT505 Dose in a Multiple Dosing Regimen.
- Lead sponsor
- Genfit
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- February 28, 2014
- Completion date
- February 28, 2015
- Enrollment
- 200 (actual)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
healthy volunteers